Cilazapril

(sih-lay-zah-pril)

PCI - Contraindicated in pregnancy

LCaution when used during lactation - Caution when used during lactation

Molecule Info

 | See TERMINOLOGY & ABBREVIATIONS |

Indication(s) & Dosage

HYPERTENSION  Adult: Initially, 1 mg orally once daily.  1st dose preferably given at bedtime.  Maintenance: 2. 5-5 mg daily. Elderly: Initially, 0. 5 mg daily. Renal impairment: Haemodialysis patients: dose to be given on non-dialysis days and dose adjusted according to response.

CrCl

Dosage Recommendation

10-40

Initial dose 0. 5 mg once daily.  Max: 2. 5 mg daily.

<10

Avoid.

Oral  Heart failure  Adult: Initially, 0. 5 mg once daily increased to a maintenance dose of 1-2. 5 mg once daily.  Max dose: 5 mg daily. Renal impairment: Haemodialysis patients: dose to be given on non-dialysis days and dose adjusted according to response.

CrCl

Dosage Recommendation

10-40

Initial dose 0. 5 mg once daily.  Max: 2. 5 mg daily.

<10

Avoid.

Special Populations: Patients taking diuretics or with mild to moderate renal impairment: 0. 5 mg daily.  Avoid in severe renal impairment.

Administration

May be taken with or without food.

Contraindications

Aortic stenosis or outflow tract obstruction; renovascular disease; ascites.  Pregnancy.

Special Precautions

Symptomatic hypertension, peripheral vascular diseases, generalized atherosclerosis, idiopathic or hereditary angioedema, heart failure; patients likely to be salt or water depleted; renal function assessed before and during therapy; monitor for proteinuria; conduct regular white blood cell counts; liver cirrhosis; surgery; anaesthesia.  Discontinue diuretics 2-3 days before starting therapy and resume later in necessary.  Lactation, elderly.

Adverse Drug Reaction(s)

Dizziness, headache, fatigue, GI disturbances, taste disturbances, persistent dry cough and other upper resp tract symptoms, skin rashes, angioedema, hypersensitivity reactions, renal impairment, hyperkalaemia, hyponatraemia, blood disorders, proteinuria, chest pain, palpitations, tachycardia, stomatitis, pancreatitis, cholestatic jaundice; alopoecia; muscle cramps; paraesthesias, mood and sleep disturbances, impotence. Potentially Fatal: Pronounced hypotension which could result in MI or stroke in patients with ischemic heart disease or cerebrovascular disease.

Drug Interactions

Additive hyperkalaemic effects with potassium-sparing diuretics, K supplements, other drugs that can cause hyperkalaemia.  Diminished antihypertensive effects with NSAIDs. Potentially Fatal: Excessive hypotension with diuretics, other antihypertensives, alcohol, other agents that lower blood pressure.

Pregnancy Category (FDA)

Category C: Either studies in animals have revealed adverse effects on the foetus and there are no controlled studies in women or studies in women and animals are not available.  Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Category D: In 2nd & 3rd trimesters.There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk.

Pharmacology

Cilazapril is the prodrug of cilazaprilat which is the active metabolite.  It causes vasodilation and reduces peripheral resistance.  It also inhibits the action of angiotensin-converting enzyme, thus preventing the conversion of angiotensin I to angiotensin II.  It may also reduce degradation of bradykinin and affect enzymes involved in the generation of prostaglandins.  Reduces both preload and afterload, and left ventricular remodelling. Onset: 1 hr. Duration: 24 hr.  Absorption: After absorption, it is rapidly metabolised in the liver to cilazaprilat, the active metabolite.  Bioavailability of cilazaprilat is about 60%.  Excretion: Cilazaprilat: Eliminated unchanged in urine; effective half-life: 9 hr after once-daily dosing.

ATC Classification

C09AA08 - cilazapril; Belongs to the class of ACE inhibitors.  Used in the treatment of cardiovascular disease.

 

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